Certified Quality

mdc certification badgeSOVAmed meets the high legal and normative requirements for the manufacture and distribution of medical devices. This was confirmed by a notified body by the certification of our Quality Management System according to EN ISO 13485:2010. We also hold an EC certificate which attests the fulfillment of the requirements of the Council Directive 93/42/EEC, Annex II.

Scope of ISO 13485 certificate
Design, Development, Production and Sales of Software to assist the reading of medical image data

Scope of the EC certificate (93/42/EEC, Annex II)
Manufacture of software for the visualization and analysis of medical image data (design, manufacture and final inspection)

Quality Objectives

  • our products support the workflow of our customers to the highest extent
  • our products are easy to use and highly user friendly
  • our used technologies are state of the art or exceed this state
  • Risks associated with the development, distribution and use of our products are detected in an early stage of the development and are considered in all phases of our development model